Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇺🇸 United States
ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 100
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 00816784020680
- Basic UDI-DI Code
- B-00816784020680
- Reference
- 2025-0067
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- LGC Clinical Diagnostics, Inc.
Additional Description
ACCURUN® 342 Chlamydia trachomatis Neisseria gonorrhoeae Positive Control Series 100 is formulated for use with in vitro diagnostic amplified test methods that detect Chlamydia trachomatis and Neisseria gonorrhoeae nucleic acids
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105080801 | BACTERIOLOGY CONTROLS - INF.IMM. |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | CE 575325 | BSI Group The Netherlands B.V. | Expired |
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